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Colombia Moves Forward with Compulsory License for HIV Medicine Dolutegravir

Neighboring Countries Including Brazil Should Now Follow Suit and Expand Access to More Affordable Generic Medicines

Bogotá/Washington, D.C. – On Friday, the government of Colombia took a historic step towards issuing its first-ever compulsory license (CL) to overcome patent barriers to HIV treatment and import less expensive generic versions of the HIV medicine dolutegravir without permission from the patent owner, ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer and Shionogi). The step by Colombia’s Secretariat of Trade and Industry invites applicants to make use of the CL for dolutegravir for generic supply, meaning that, within the next ten days, manufacturers need to express an interest to supply the drug to Colombia under this CL. The Colombian government has already established the royalty rates that that the manufacturers would need to pay to the patent owner for the use of dolutegravir without the authorization of the patent owner, and has determined that the CL would be in effect until at least April 28th, 2026 or for as long as i) the patents for dolutegravir are valid; ii) the public interest reasons for the CL remain; iii) the access goals are unmet. Colombia’s actions make use of a legitimate mechanism enshrined in international law, and come after more than 120 civil society organisations, academics, public health experts, and activists called on the Colombian Minister of Health, Guillermo Alfonso Jaramillo to support expanding access to dolutegravir.

Dolutegravir is recommended as part of the preferred first-line treatment regimen for people living with HIV, including during pregnancy, as per the guidance of the World Health Organization (WHO). Médecins Sans Frontières/Doctors Without Borders (MSF) uses a dolutegravir-based first-line HIV treatment regimen across its HIV/AIDS programs, and has seen patients benefit from the fewer side effects the drug causes and a lower risk of developing resistance.

However, in many of the countries where MSF works, access to more affordable generic versions of dolutegravir remains a challenge. In Colombia, due to patent barriers and high prices, MSF has not been able to introduce dolutegravir in its medical projects. Although generic versions of dolutegravir are available internationally for a fraction of ViiV’s price through voluntary licenses with the Medicines Patent Pool (MPP), ViiV excluded Colombia and many middle-income countries from being able to benefit from its license with MPP, allowing ViiV to maintain its monopoly and continue to charge high prices in Colombia and other countries excluded from the license. A CL would remove the patent barriers in Colombia and enable access to more affordable generic versions of dolutegravir for all people who need it, including by opening the door for MSF to introduce dolutegravir in our medical projects.

Many governments have used the CL mechanism to address access to medicines challenges, including to remedy anticompetitive practices or to facilitate government procurement of medicines. However, it remains generally underused as a mechanism to advance access to medicines largely because pharmaceutical corporations lobby so strongly against it with governments. Colombia’s move therefore sets an encouraging example for other countries in the region and beyond, on how they can implement compulsory licensing to improve access to medicines.

Francisco Viegas, Medical Innovation Policy Advisor, MSF Access Campaign:

“It’s a momentous achievement that Colombia is inviting manufacturers and suppliers to provide generic versions of dolutegravir for people who need this key HIV medicine through a compulsory license, as this is a first-of-its-kind step taken towards a compulsory license by the Colombian government, and sends a strong signal that it is indeed possible to put people and public health first.

“We expect the Colombian Secretariat of Trade and Industry to swiftly review the applications to use the compulsory license in the coming days. Once this is finalised and Colombia issues the compulsory license, the government will be able to increase access to more affordable generic versions of dolutegravir and save more lives. We therefore also urge other countries to take a page out of Colombia’s book: Brazil is facing challenges  in supplying affordable generic versions of dolutegravir, despite having national production capacity, because it is blocked by a patent, so issuing a compulsory license would allow access to more affordable generic versions of this drug to be produced or imported and could substantially change the lives of people with HIV in Brazil.”

Luz Marina Umbasia Bernal, director of Global Humanitarian Progress Corporation Colombia:

“The materialization of a compulsory license for dolutegravir constitutes a step forward and an achievement for Colombia and the Latin American region after many years of promoting the effective use of health safeguards for another essential medicines, HIV, cancer, hepatitis and even treatments for COVID 19 during pandemic.

“This action sets a precedent for other countries and creates hope for many who do not have access to the medicines they need. The appropriate use of these health safeguards further contributes to the long-term sustainability of health systems by ensuring equitable and affordable access to medicines in line with the Sustainable Development Goals on Good Health and Well Being; it reaffirms the right to use such TRIPS flexibilities.”

Peter Maybarduk, Public Citizen’s access to medicines director based in Washington, D.C.:

“Colombia is planting a flag for global health equity, following the deaths and injustice of the Covid emergency. This should inspire regional action to challenge patent barriers and improve treatment access, towards an AIDS-free generation. Generics manufacturers now can apply for a license to provide affordable dolutegravir in Colombia, using competition to drive down costs and meet health needs.”